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New tickborne virus emerges in China
A new virus has been associated with febrile illness in China in patients with histories of tick bites. The data on the discovery, isolation, and characterization of the virus were reported in the New England Journal of Medicine.
The segmented RNA virus now known as Alongshan virus (ALSV) “belongs to the unclassified jingmenvirus group in the family Flaviviridae, which includes the genera flavivirus, pestivirus, hepacivirus, and pegivirus,” wrote Ze-Dong Wang, PhD, of Foshan (China) University, and colleagues.
The index patient with ALSV was a 42-year-old female farmer from the town of Alongshan, China, who presented to a regional hospital in April 2017 with fever, headache, and a history of tick bites. The initial clinical features were similar to those seen in tickborne diseases, but a blood sample showed no RNA or antibodies for tickborne encephalitis virus. Investigators obtained a blood specimen from the index patient 4 days after the onset of illness. After culturing the sample, the investigators extracted the viral RNA genome and sequenced it.
Sequence analysis found that the new pathogen was related to segmented viruses in the jingmenvirus group of the family Flaviviridae; however, “comparison of the amino acids further confirmed that ALSV is genetically distinct from other jingmenviruses,” the investigators said.
The investigators identified 374 patients who presented to the hospital with fever, headache, and a history of tick bites during May 2017–September 2017; 86 patients had confirmed ALSV infections via nested reverse-transcription polymerase chain reaction testing. Of these, 63 were men and 84 were farmers or forestry workers. Although ticks were common in the patients’ environments, no other evidence of tickborne diseases was noted. The patients ranged in age from 24 to 77 years, and the average duration of the infection was 3-7 days.
Symptoms were nonspecific and included fever, headache, fatigue, nausea, cough, and sore throat. All 86 patients were treated with intravenous ribavirin (0.5 g/day), and intramuscular benzylpenicillin sodium (2 million U/day) for 3-5 days. The median hospital stay was 11 days, and no deaths or long-term clinical complications occurred in the confirmed ALSV patients.
ALSV is similar to other jingmenviruses, but is distinct from other infections in part because of the absence of a rash or jaundice, the investigators said.
Although the investigators said they suspected the disease was carried by ticks, they would not rule out mosquitoes as a possible carrier because ALSV RNA was found in mosquitoes in a Northeastern province of China, and the RNA from those mosquitoes was found to be genetically related to the RNA assessed in this study.
Overall, “our findings suggest that ALSV may be the cause of a previously unknown febrile disease, and more studies should be conducted to determine the geographic distribution of this disease outside its current areas of identification,” they said.
The research was supported by the National Key Research and Development Program of China and the National Natural Science Foundation of China.
SOURCE: Wang Z et al. N Engl J Med. 2019 May 29. doi: 10.1056/NEJMoa1805068.
New technology and genomic surveys will continue to help identify emerging pathogens, however, “they may provide limited value in understanding the mechanisms of disease emergence,” wrote Nikos Vasilakis, PhD, and David H. Walker, MD, in an accompanying editorial. An active surveillance program allowed the investigators of the previously unknown tickborne pathogen in China to identify a group of patients with similar history. The new pathogen was classified as one of the jingmenviruses, which “reveal that RNA virus segmentation is an evolutionary process that has occurred in previously unanticipated circumstances.” This study by Wang et al. shows that these viruses are not limited to arthropod hosts but can be dangerous to humans.
The new pathogen had likely been evolving for some time before it was discovered, the editorialists said. “The key to making such discoveries is the study of ill persons, isolation of the etiologic agent, use of tools that will reveal the nature of the agent (e.g., electron microscopy), and application of the appropriate tools for definitive characterization (e.g., sequencing of the RNA genome),” they emphasized. However, to mitigate outbreaks, “proactive, real-time surveillance” may be more cost effective than extensive genomic surveys, they noted (N Engl J Med. 2019 May 29. doi: 10.1056/NEJMe1901212).
Dr. Vasilakis and Dr. Walker are affiliated with the department of pathology, Center for Biodefense and Emerging Infectious Diseases, Center for Tropical Diseases, and the Institute for Human Infections and Immunity, University of Texas Medical Branch, Galveston. They had no financial conflicts to disclose.
New technology and genomic surveys will continue to help identify emerging pathogens, however, “they may provide limited value in understanding the mechanisms of disease emergence,” wrote Nikos Vasilakis, PhD, and David H. Walker, MD, in an accompanying editorial. An active surveillance program allowed the investigators of the previously unknown tickborne pathogen in China to identify a group of patients with similar history. The new pathogen was classified as one of the jingmenviruses, which “reveal that RNA virus segmentation is an evolutionary process that has occurred in previously unanticipated circumstances.” This study by Wang et al. shows that these viruses are not limited to arthropod hosts but can be dangerous to humans.
The new pathogen had likely been evolving for some time before it was discovered, the editorialists said. “The key to making such discoveries is the study of ill persons, isolation of the etiologic agent, use of tools that will reveal the nature of the agent (e.g., electron microscopy), and application of the appropriate tools for definitive characterization (e.g., sequencing of the RNA genome),” they emphasized. However, to mitigate outbreaks, “proactive, real-time surveillance” may be more cost effective than extensive genomic surveys, they noted (N Engl J Med. 2019 May 29. doi: 10.1056/NEJMe1901212).
Dr. Vasilakis and Dr. Walker are affiliated with the department of pathology, Center for Biodefense and Emerging Infectious Diseases, Center for Tropical Diseases, and the Institute for Human Infections and Immunity, University of Texas Medical Branch, Galveston. They had no financial conflicts to disclose.
New technology and genomic surveys will continue to help identify emerging pathogens, however, “they may provide limited value in understanding the mechanisms of disease emergence,” wrote Nikos Vasilakis, PhD, and David H. Walker, MD, in an accompanying editorial. An active surveillance program allowed the investigators of the previously unknown tickborne pathogen in China to identify a group of patients with similar history. The new pathogen was classified as one of the jingmenviruses, which “reveal that RNA virus segmentation is an evolutionary process that has occurred in previously unanticipated circumstances.” This study by Wang et al. shows that these viruses are not limited to arthropod hosts but can be dangerous to humans.
The new pathogen had likely been evolving for some time before it was discovered, the editorialists said. “The key to making such discoveries is the study of ill persons, isolation of the etiologic agent, use of tools that will reveal the nature of the agent (e.g., electron microscopy), and application of the appropriate tools for definitive characterization (e.g., sequencing of the RNA genome),” they emphasized. However, to mitigate outbreaks, “proactive, real-time surveillance” may be more cost effective than extensive genomic surveys, they noted (N Engl J Med. 2019 May 29. doi: 10.1056/NEJMe1901212).
Dr. Vasilakis and Dr. Walker are affiliated with the department of pathology, Center for Biodefense and Emerging Infectious Diseases, Center for Tropical Diseases, and the Institute for Human Infections and Immunity, University of Texas Medical Branch, Galveston. They had no financial conflicts to disclose.
A new virus has been associated with febrile illness in China in patients with histories of tick bites. The data on the discovery, isolation, and characterization of the virus were reported in the New England Journal of Medicine.
The segmented RNA virus now known as Alongshan virus (ALSV) “belongs to the unclassified jingmenvirus group in the family Flaviviridae, which includes the genera flavivirus, pestivirus, hepacivirus, and pegivirus,” wrote Ze-Dong Wang, PhD, of Foshan (China) University, and colleagues.
The index patient with ALSV was a 42-year-old female farmer from the town of Alongshan, China, who presented to a regional hospital in April 2017 with fever, headache, and a history of tick bites. The initial clinical features were similar to those seen in tickborne diseases, but a blood sample showed no RNA or antibodies for tickborne encephalitis virus. Investigators obtained a blood specimen from the index patient 4 days after the onset of illness. After culturing the sample, the investigators extracted the viral RNA genome and sequenced it.
Sequence analysis found that the new pathogen was related to segmented viruses in the jingmenvirus group of the family Flaviviridae; however, “comparison of the amino acids further confirmed that ALSV is genetically distinct from other jingmenviruses,” the investigators said.
The investigators identified 374 patients who presented to the hospital with fever, headache, and a history of tick bites during May 2017–September 2017; 86 patients had confirmed ALSV infections via nested reverse-transcription polymerase chain reaction testing. Of these, 63 were men and 84 were farmers or forestry workers. Although ticks were common in the patients’ environments, no other evidence of tickborne diseases was noted. The patients ranged in age from 24 to 77 years, and the average duration of the infection was 3-7 days.
Symptoms were nonspecific and included fever, headache, fatigue, nausea, cough, and sore throat. All 86 patients were treated with intravenous ribavirin (0.5 g/day), and intramuscular benzylpenicillin sodium (2 million U/day) for 3-5 days. The median hospital stay was 11 days, and no deaths or long-term clinical complications occurred in the confirmed ALSV patients.
ALSV is similar to other jingmenviruses, but is distinct from other infections in part because of the absence of a rash or jaundice, the investigators said.
Although the investigators said they suspected the disease was carried by ticks, they would not rule out mosquitoes as a possible carrier because ALSV RNA was found in mosquitoes in a Northeastern province of China, and the RNA from those mosquitoes was found to be genetically related to the RNA assessed in this study.
Overall, “our findings suggest that ALSV may be the cause of a previously unknown febrile disease, and more studies should be conducted to determine the geographic distribution of this disease outside its current areas of identification,” they said.
The research was supported by the National Key Research and Development Program of China and the National Natural Science Foundation of China.
SOURCE: Wang Z et al. N Engl J Med. 2019 May 29. doi: 10.1056/NEJMoa1805068.
A new virus has been associated with febrile illness in China in patients with histories of tick bites. The data on the discovery, isolation, and characterization of the virus were reported in the New England Journal of Medicine.
The segmented RNA virus now known as Alongshan virus (ALSV) “belongs to the unclassified jingmenvirus group in the family Flaviviridae, which includes the genera flavivirus, pestivirus, hepacivirus, and pegivirus,” wrote Ze-Dong Wang, PhD, of Foshan (China) University, and colleagues.
The index patient with ALSV was a 42-year-old female farmer from the town of Alongshan, China, who presented to a regional hospital in April 2017 with fever, headache, and a history of tick bites. The initial clinical features were similar to those seen in tickborne diseases, but a blood sample showed no RNA or antibodies for tickborne encephalitis virus. Investigators obtained a blood specimen from the index patient 4 days after the onset of illness. After culturing the sample, the investigators extracted the viral RNA genome and sequenced it.
Sequence analysis found that the new pathogen was related to segmented viruses in the jingmenvirus group of the family Flaviviridae; however, “comparison of the amino acids further confirmed that ALSV is genetically distinct from other jingmenviruses,” the investigators said.
The investigators identified 374 patients who presented to the hospital with fever, headache, and a history of tick bites during May 2017–September 2017; 86 patients had confirmed ALSV infections via nested reverse-transcription polymerase chain reaction testing. Of these, 63 were men and 84 were farmers or forestry workers. Although ticks were common in the patients’ environments, no other evidence of tickborne diseases was noted. The patients ranged in age from 24 to 77 years, and the average duration of the infection was 3-7 days.
Symptoms were nonspecific and included fever, headache, fatigue, nausea, cough, and sore throat. All 86 patients were treated with intravenous ribavirin (0.5 g/day), and intramuscular benzylpenicillin sodium (2 million U/day) for 3-5 days. The median hospital stay was 11 days, and no deaths or long-term clinical complications occurred in the confirmed ALSV patients.
ALSV is similar to other jingmenviruses, but is distinct from other infections in part because of the absence of a rash or jaundice, the investigators said.
Although the investigators said they suspected the disease was carried by ticks, they would not rule out mosquitoes as a possible carrier because ALSV RNA was found in mosquitoes in a Northeastern province of China, and the RNA from those mosquitoes was found to be genetically related to the RNA assessed in this study.
Overall, “our findings suggest that ALSV may be the cause of a previously unknown febrile disease, and more studies should be conducted to determine the geographic distribution of this disease outside its current areas of identification,” they said.
The research was supported by the National Key Research and Development Program of China and the National Natural Science Foundation of China.
SOURCE: Wang Z et al. N Engl J Med. 2019 May 29. doi: 10.1056/NEJMoa1805068.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Severe respiratory failure strikes healthy teens on trimethoprim-sulfamethoxazole
TMP-SMX, a frequently prescribed antibiotic, has been associated with “idiosyncratic adverse drug reactions, including cutaneous reactions and hypersensitivity syndromes,” but pulmonary complications are rare, especially in children, wrote Jenna O. Miller, MD, of the University of Missouri–Kansas City and colleagues.
In a case series published in Pediatrics, the researchers described the patients, who were aged 13-18 years; the 18-year-old was male, the others were female. Four of the patients (three females, one male) were taking TMP-SMX for acne vulgaris. One of these patients, a 13-year-old girl, underwent a bilateral lung and heart transplant after developing interstitial lung disease and died as a result of solid organ transplant complications. The other death occurred in a 15-year-old girl who was taking TMP-SMX to treat a urinary tract infection. This patient developed interstitial lung disease and died of complications from the disease while awaiting a lung transplant.
“In all cases, patients were transferred to academic medical facilities, and pediatric pulmonologists and infectious diseases specialists performed extensive evaluations,” the researchers wrote. The patients did not improve when the drug was discontinued, and four of the five were considered or listed for organ transplants. The spectrum of disease was varied among the patients, and the pathophysiology remains poorly understood.
Although no clinical test could confirm causality between TMP-SMX and ARDS in the five teens, “the extensive negative workup, paired with recent TMP-SMX exposure and similarity among these cases, raises the possibility that the observed ARDS was TMP-SMX triggered,” they wrote.
The researchers had no financial conflicts to disclose.
SOURCE: Miller JO et al. Pediatrics. 2019 May 29. doi: 10.1542/peds.2018.3242.
TMP-SMX, a frequently prescribed antibiotic, has been associated with “idiosyncratic adverse drug reactions, including cutaneous reactions and hypersensitivity syndromes,” but pulmonary complications are rare, especially in children, wrote Jenna O. Miller, MD, of the University of Missouri–Kansas City and colleagues.
In a case series published in Pediatrics, the researchers described the patients, who were aged 13-18 years; the 18-year-old was male, the others were female. Four of the patients (three females, one male) were taking TMP-SMX for acne vulgaris. One of these patients, a 13-year-old girl, underwent a bilateral lung and heart transplant after developing interstitial lung disease and died as a result of solid organ transplant complications. The other death occurred in a 15-year-old girl who was taking TMP-SMX to treat a urinary tract infection. This patient developed interstitial lung disease and died of complications from the disease while awaiting a lung transplant.
“In all cases, patients were transferred to academic medical facilities, and pediatric pulmonologists and infectious diseases specialists performed extensive evaluations,” the researchers wrote. The patients did not improve when the drug was discontinued, and four of the five were considered or listed for organ transplants. The spectrum of disease was varied among the patients, and the pathophysiology remains poorly understood.
Although no clinical test could confirm causality between TMP-SMX and ARDS in the five teens, “the extensive negative workup, paired with recent TMP-SMX exposure and similarity among these cases, raises the possibility that the observed ARDS was TMP-SMX triggered,” they wrote.
The researchers had no financial conflicts to disclose.
SOURCE: Miller JO et al. Pediatrics. 2019 May 29. doi: 10.1542/peds.2018.3242.
TMP-SMX, a frequently prescribed antibiotic, has been associated with “idiosyncratic adverse drug reactions, including cutaneous reactions and hypersensitivity syndromes,” but pulmonary complications are rare, especially in children, wrote Jenna O. Miller, MD, of the University of Missouri–Kansas City and colleagues.
In a case series published in Pediatrics, the researchers described the patients, who were aged 13-18 years; the 18-year-old was male, the others were female. Four of the patients (three females, one male) were taking TMP-SMX for acne vulgaris. One of these patients, a 13-year-old girl, underwent a bilateral lung and heart transplant after developing interstitial lung disease and died as a result of solid organ transplant complications. The other death occurred in a 15-year-old girl who was taking TMP-SMX to treat a urinary tract infection. This patient developed interstitial lung disease and died of complications from the disease while awaiting a lung transplant.
“In all cases, patients were transferred to academic medical facilities, and pediatric pulmonologists and infectious diseases specialists performed extensive evaluations,” the researchers wrote. The patients did not improve when the drug was discontinued, and four of the five were considered or listed for organ transplants. The spectrum of disease was varied among the patients, and the pathophysiology remains poorly understood.
Although no clinical test could confirm causality between TMP-SMX and ARDS in the five teens, “the extensive negative workup, paired with recent TMP-SMX exposure and similarity among these cases, raises the possibility that the observed ARDS was TMP-SMX triggered,” they wrote.
The researchers had no financial conflicts to disclose.
SOURCE: Miller JO et al. Pediatrics. 2019 May 29. doi: 10.1542/peds.2018.3242.
FROM PEDIATRICS
Team sports may mitigate tough childhoods
Individuals who experienced adverse childhood experiences but also played team sports as teens were less likely to have mental health problems in adulthood than those with childhood challenges who did not play sports, based on data from nearly 5,000 individuals.
Physical and mental health problems are more prominent throughout life among those exposed to adverse childhood experiences (ACEs), and physical activity in general and team sports in particular have been shown to improve mental health, wrote Molly C. Easterlin, MD, of the University of California, Los Angeles, and colleagues.
In a study published in JAMA Pediatrics, the researchers used data from the National Longitudinal Study of Adolescent to Adult Health to compare the development of depression, anxiety, or depressive symptoms among those with childhood ACEs who did and did not participate in team sports in adolescence.
Overall, team sports participation was significantly associated with reduced odds of depression (adjusted odds ratio, 0.76), anxiety (aOR, 0.70), and depressive symptoms (aOR, 0.85) in young adulthood for individuals with ACEs, compared with those with ACEs who did not play team sports.
Of 9,668 adolescents in the study, 4,888 individuals reported one or more ACEs and 2,084 reported two or more ACEs. The researchers compared data from the 1994-1995 school year when participants were in grades 7-12 and in 2008 to assess their mental health as young adults (aged 24-32 years).
No significant differences in associations appeared between sports participation and mental health between males and females.
The results were limited by several factors including the study design that did not allow for causality and the potential social desirability bias that might lead to underreporting ACEs, Dr. Easterlin and associates noted.
Nonetheless, “given that participation in team sports was associated with improved adult mental health among those with ACEs, and parents might consider enrolling their children with ACEs in team sports,” they wrote.
Dr. Easterlin is supported by the Cedars-Sinai Medical Center via the UCLA National Clinician Scholars Program. The authors reported no conflicts of interest.
SOURCE: Easterlin MC et al. JAMA Pediatr. 2019 May 28. doi: 10.1001/jamapediatrics.2019.1212.
Approximately half of children suffer an adverse childhood experience (ACE) that can negatively affect their mental health throughout life, and “team sports can be an avenue to interrupt these negative sequelae and address the important public health burden of depression,” wrote Amanda E. Paluch, PhD; Nia Heard-Garris, MD, MSc; and Mercedes R. Carnethon, PhD.
However, a significant socioeconomic disparity in team sports for children continues to grow in the United States, driven in part by a youth sports industry and culture that caters to high-income families looking to improve their children’s performance. “Although unintentional, these expenses leave behind lower-income children,” many of whom may be at increased risk for ACEs, the editorialists noted. Many inexpensive, community-based recreation leagues, especially in low-income areas, are often underfunded and unable to update facilities and attract more participants.
The benefits of team sports appear to go beyond the physical, as the study by Easterlin et al. suggests that feeling accepted and connected as part of a team has an impact on mental health. Also, the winning and losing of sports helps build emotional resilience that carries over to other areas of life, the editorialists added.
“Optimizing the opportunities for sports during adolescence requires relatively few resources and is a low-cost way to improve quality of life and reduce the population burden of mental health disorders, especially for adolescents and young adults with histories of ACEs,” they concluded.
Dr. Paluch and Dr. Carnethon are affiliated with the department of preventive medicine and Dr. Heard-Garris is affiliated with the department of pediatrics at Northwestern University, Chicago. They commented on the study by Easterlin et al (JAMA Pediatr. 2019 May 28. doi:10.1001/jamapediatrics.2019.1209). They reported no conflicts of interest.
Approximately half of children suffer an adverse childhood experience (ACE) that can negatively affect their mental health throughout life, and “team sports can be an avenue to interrupt these negative sequelae and address the important public health burden of depression,” wrote Amanda E. Paluch, PhD; Nia Heard-Garris, MD, MSc; and Mercedes R. Carnethon, PhD.
However, a significant socioeconomic disparity in team sports for children continues to grow in the United States, driven in part by a youth sports industry and culture that caters to high-income families looking to improve their children’s performance. “Although unintentional, these expenses leave behind lower-income children,” many of whom may be at increased risk for ACEs, the editorialists noted. Many inexpensive, community-based recreation leagues, especially in low-income areas, are often underfunded and unable to update facilities and attract more participants.
The benefits of team sports appear to go beyond the physical, as the study by Easterlin et al. suggests that feeling accepted and connected as part of a team has an impact on mental health. Also, the winning and losing of sports helps build emotional resilience that carries over to other areas of life, the editorialists added.
“Optimizing the opportunities for sports during adolescence requires relatively few resources and is a low-cost way to improve quality of life and reduce the population burden of mental health disorders, especially for adolescents and young adults with histories of ACEs,” they concluded.
Dr. Paluch and Dr. Carnethon are affiliated with the department of preventive medicine and Dr. Heard-Garris is affiliated with the department of pediatrics at Northwestern University, Chicago. They commented on the study by Easterlin et al (JAMA Pediatr. 2019 May 28. doi:10.1001/jamapediatrics.2019.1209). They reported no conflicts of interest.
Approximately half of children suffer an adverse childhood experience (ACE) that can negatively affect their mental health throughout life, and “team sports can be an avenue to interrupt these negative sequelae and address the important public health burden of depression,” wrote Amanda E. Paluch, PhD; Nia Heard-Garris, MD, MSc; and Mercedes R. Carnethon, PhD.
However, a significant socioeconomic disparity in team sports for children continues to grow in the United States, driven in part by a youth sports industry and culture that caters to high-income families looking to improve their children’s performance. “Although unintentional, these expenses leave behind lower-income children,” many of whom may be at increased risk for ACEs, the editorialists noted. Many inexpensive, community-based recreation leagues, especially in low-income areas, are often underfunded and unable to update facilities and attract more participants.
The benefits of team sports appear to go beyond the physical, as the study by Easterlin et al. suggests that feeling accepted and connected as part of a team has an impact on mental health. Also, the winning and losing of sports helps build emotional resilience that carries over to other areas of life, the editorialists added.
“Optimizing the opportunities for sports during adolescence requires relatively few resources and is a low-cost way to improve quality of life and reduce the population burden of mental health disorders, especially for adolescents and young adults with histories of ACEs,” they concluded.
Dr. Paluch and Dr. Carnethon are affiliated with the department of preventive medicine and Dr. Heard-Garris is affiliated with the department of pediatrics at Northwestern University, Chicago. They commented on the study by Easterlin et al (JAMA Pediatr. 2019 May 28. doi:10.1001/jamapediatrics.2019.1209). They reported no conflicts of interest.
Individuals who experienced adverse childhood experiences but also played team sports as teens were less likely to have mental health problems in adulthood than those with childhood challenges who did not play sports, based on data from nearly 5,000 individuals.
Physical and mental health problems are more prominent throughout life among those exposed to adverse childhood experiences (ACEs), and physical activity in general and team sports in particular have been shown to improve mental health, wrote Molly C. Easterlin, MD, of the University of California, Los Angeles, and colleagues.
In a study published in JAMA Pediatrics, the researchers used data from the National Longitudinal Study of Adolescent to Adult Health to compare the development of depression, anxiety, or depressive symptoms among those with childhood ACEs who did and did not participate in team sports in adolescence.
Overall, team sports participation was significantly associated with reduced odds of depression (adjusted odds ratio, 0.76), anxiety (aOR, 0.70), and depressive symptoms (aOR, 0.85) in young adulthood for individuals with ACEs, compared with those with ACEs who did not play team sports.
Of 9,668 adolescents in the study, 4,888 individuals reported one or more ACEs and 2,084 reported two or more ACEs. The researchers compared data from the 1994-1995 school year when participants were in grades 7-12 and in 2008 to assess their mental health as young adults (aged 24-32 years).
No significant differences in associations appeared between sports participation and mental health between males and females.
The results were limited by several factors including the study design that did not allow for causality and the potential social desirability bias that might lead to underreporting ACEs, Dr. Easterlin and associates noted.
Nonetheless, “given that participation in team sports was associated with improved adult mental health among those with ACEs, and parents might consider enrolling their children with ACEs in team sports,” they wrote.
Dr. Easterlin is supported by the Cedars-Sinai Medical Center via the UCLA National Clinician Scholars Program. The authors reported no conflicts of interest.
SOURCE: Easterlin MC et al. JAMA Pediatr. 2019 May 28. doi: 10.1001/jamapediatrics.2019.1212.
Individuals who experienced adverse childhood experiences but also played team sports as teens were less likely to have mental health problems in adulthood than those with childhood challenges who did not play sports, based on data from nearly 5,000 individuals.
Physical and mental health problems are more prominent throughout life among those exposed to adverse childhood experiences (ACEs), and physical activity in general and team sports in particular have been shown to improve mental health, wrote Molly C. Easterlin, MD, of the University of California, Los Angeles, and colleagues.
In a study published in JAMA Pediatrics, the researchers used data from the National Longitudinal Study of Adolescent to Adult Health to compare the development of depression, anxiety, or depressive symptoms among those with childhood ACEs who did and did not participate in team sports in adolescence.
Overall, team sports participation was significantly associated with reduced odds of depression (adjusted odds ratio, 0.76), anxiety (aOR, 0.70), and depressive symptoms (aOR, 0.85) in young adulthood for individuals with ACEs, compared with those with ACEs who did not play team sports.
Of 9,668 adolescents in the study, 4,888 individuals reported one or more ACEs and 2,084 reported two or more ACEs. The researchers compared data from the 1994-1995 school year when participants were in grades 7-12 and in 2008 to assess their mental health as young adults (aged 24-32 years).
No significant differences in associations appeared between sports participation and mental health between males and females.
The results were limited by several factors including the study design that did not allow for causality and the potential social desirability bias that might lead to underreporting ACEs, Dr. Easterlin and associates noted.
Nonetheless, “given that participation in team sports was associated with improved adult mental health among those with ACEs, and parents might consider enrolling their children with ACEs in team sports,” they wrote.
Dr. Easterlin is supported by the Cedars-Sinai Medical Center via the UCLA National Clinician Scholars Program. The authors reported no conflicts of interest.
SOURCE: Easterlin MC et al. JAMA Pediatr. 2019 May 28. doi: 10.1001/jamapediatrics.2019.1212.
FROM JAMA PEDIATRICS
FDA permits marketing of Zika diagnostic test
A Zika virus test initially authorized only for emergency use has now been approved for use in nonemergency situations, according to a statement from the Food and Drug Administration.
The ZIKV Detect 2.0 IgM Capture ELISA (enzyme-linked immunosorbent assay) is now authorized for use in patients with clinical signs and symptoms consistent with Zika virus infection, as well as those who meet the Centers for Disease Control and Prevention epidemiologic criteria, including residence in or travel to a region deemed high risk because of active Zika transmission.
The test is designed to identify Zika antibodies in the blood, and the FDA cited a review of clinical trial data and analytic data to support the test’s safety and effectiveness.
“Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions,” the FDA stated.
The ZIKV Detect 2.0 IgM Capture ELISA, initially approved in 2016, had been authorized by the FDA only for emergency use, along with other tests for detecting Zika virus, under the under the FDA’s Emergency Use Authorization (EUA) authority.
The FDA granted marketing authorization to test manufacturer InBios International.
The FDA is communicating with four EUA holders to gather information to evaluate whether the FDA should revoke the EUAs for these specific tests. The marketing authorization of ZIKV Detect 2.0 IgM Capture ELISA does not impact the availability of the other 14 Zika nucleic acid diagnostics available under EUAs.
The Zika virus, typically transmitted by an infected mosquito, is especially a risk for pregnant women as the fetus may experience neurologic complications and microcephaly as a result of infection.
A Zika virus test initially authorized only for emergency use has now been approved for use in nonemergency situations, according to a statement from the Food and Drug Administration.
The ZIKV Detect 2.0 IgM Capture ELISA (enzyme-linked immunosorbent assay) is now authorized for use in patients with clinical signs and symptoms consistent with Zika virus infection, as well as those who meet the Centers for Disease Control and Prevention epidemiologic criteria, including residence in or travel to a region deemed high risk because of active Zika transmission.
The test is designed to identify Zika antibodies in the blood, and the FDA cited a review of clinical trial data and analytic data to support the test’s safety and effectiveness.
“Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions,” the FDA stated.
The ZIKV Detect 2.0 IgM Capture ELISA, initially approved in 2016, had been authorized by the FDA only for emergency use, along with other tests for detecting Zika virus, under the under the FDA’s Emergency Use Authorization (EUA) authority.
The FDA granted marketing authorization to test manufacturer InBios International.
The FDA is communicating with four EUA holders to gather information to evaluate whether the FDA should revoke the EUAs for these specific tests. The marketing authorization of ZIKV Detect 2.0 IgM Capture ELISA does not impact the availability of the other 14 Zika nucleic acid diagnostics available under EUAs.
The Zika virus, typically transmitted by an infected mosquito, is especially a risk for pregnant women as the fetus may experience neurologic complications and microcephaly as a result of infection.
A Zika virus test initially authorized only for emergency use has now been approved for use in nonemergency situations, according to a statement from the Food and Drug Administration.
The ZIKV Detect 2.0 IgM Capture ELISA (enzyme-linked immunosorbent assay) is now authorized for use in patients with clinical signs and symptoms consistent with Zika virus infection, as well as those who meet the Centers for Disease Control and Prevention epidemiologic criteria, including residence in or travel to a region deemed high risk because of active Zika transmission.
The test is designed to identify Zika antibodies in the blood, and the FDA cited a review of clinical trial data and analytic data to support the test’s safety and effectiveness.
“Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions,” the FDA stated.
The ZIKV Detect 2.0 IgM Capture ELISA, initially approved in 2016, had been authorized by the FDA only for emergency use, along with other tests for detecting Zika virus, under the under the FDA’s Emergency Use Authorization (EUA) authority.
The FDA granted marketing authorization to test manufacturer InBios International.
The FDA is communicating with four EUA holders to gather information to evaluate whether the FDA should revoke the EUAs for these specific tests. The marketing authorization of ZIKV Detect 2.0 IgM Capture ELISA does not impact the availability of the other 14 Zika nucleic acid diagnostics available under EUAs.
The Zika virus, typically transmitted by an infected mosquito, is especially a risk for pregnant women as the fetus may experience neurologic complications and microcephaly as a result of infection.
Keep sports fun, keep kids playing
according to a clinical report from the American Academy of Pediatrics’ Council on Sports Medicine and Fitness.
In the report, “Organized Sports for Children, Preadolescents, and Adolescents,” published online in Pediatrics, the authors addressed the risks and benefits of organized sports for children and teens and offered guidance for how clinicians, schools, and communities can involve more children in sports programs.
The authors emphasized the role of free play and the development of skills for children younger than 6 years. However, they wrote that you and parents should encourage organized sports – with emphasis on physical activity enjoyment – for children older than 6 years at a range of skill levels.
“Aspects of readiness to consider are motor skill acquisition, ability to combine those skills, and attention span,” according to the authors, who noted that most children younger than 6 years may not yet have the skills and attention for organized sports.
You also can remind parents to step back from pushing children into particular sports. Allowing children to choose which activities to try helps keep the focus on fun, even if the child’s idea of fun may differ from parental ideas. “Forcing children to participate in organized sports (or any physical activity) is likely to decrease fun in the activity and discourage future participation,” according to the authors.
They recognize barriers to organized sports for children from low socioeconomic backgrounds and advise communities to try to reduce them; other recommendations include having more options for organized sports at a range of skill levels to encourage participation and long-term involvement, and promoting physical activity.
“If we offer children a variety of sports for all skill levels, they are more likely to try new activities and stick with the ones they enjoy,” Kelsey Logan, MD, a coauthor of the report, said in a statement. “The interest should start with the child, not the parent.”
“Families can help by encouraging children to ‘sample’ sports, so they can figure out what they find enjoyable,” he said. “Ideally, there is an activity for everyone, with the focus on having fun.”
“Given the epidemic of obesity and all of its accompanying medical conditions, it is important to find ways to keep kids physically active. Organized sports participation is one tactic to accomplish this,” the authors said.
They acknowledge the potential risks involved in organized sports such as sports injuries, bullying, and burnout, but also advise empowering parents to support a positive coaching environment with playing time for all participants so they can enjoy the physical and mental benefits of being on a team.
“Young athletes typically learn skills and values that they can use in everyday life,” Steven Cuff, MD, coauthor of the report, said in a statement. “The camaraderie and teamwork needed on a playing field offers lasting lessons on personal responsibility, sportsmanship, goal-setting, and emotional control.”
Children with developmental and neurologic disabilities also can benefit from organized sports participation in programs such as Special Olympics, the authors said.
The report authors had no financial conflicts to disclose.
SOURCE: Logan K et al. Pediatrics. 2019 May 20. doi: 10.1542/peds.2019-0997.
“I think it is quite timely with the obesity epidemic and lack of PE in schools to highlight how important physical activity is for children, and organized sports is one of the ways to accomplish that,” Andrew Gregory, MD, said in an interview.
“I think the summary of both benefits and risks is well informed and complete,” he said.
However, “I think most pediatricians and parents are aware of the physical benefits of exercise, but many may be unaware of the psychological and social benefits,” Dr. Gregory noted. “It is also important that parents and coaches understand that bullying and hazing have no place in organized sports and should not be tolerated.”
“I think the most important thing for clinicians to pass on is that the benefits of organized sports far outweigh the risks,” he said. The challenge is, “How do we better incorporate organized sports into schools and community organizations so that more children have access?”
Dr. Gregory is an associate professor of orthopaedics, neurosurgery & pediatrics at Vanderbilt University in Nashville, Tenn., and serves as codirector of the Vanderbilt Sports Concussion Center. He had no financial conflicts to disclose.
“I think it is quite timely with the obesity epidemic and lack of PE in schools to highlight how important physical activity is for children, and organized sports is one of the ways to accomplish that,” Andrew Gregory, MD, said in an interview.
“I think the summary of both benefits and risks is well informed and complete,” he said.
However, “I think most pediatricians and parents are aware of the physical benefits of exercise, but many may be unaware of the psychological and social benefits,” Dr. Gregory noted. “It is also important that parents and coaches understand that bullying and hazing have no place in organized sports and should not be tolerated.”
“I think the most important thing for clinicians to pass on is that the benefits of organized sports far outweigh the risks,” he said. The challenge is, “How do we better incorporate organized sports into schools and community organizations so that more children have access?”
Dr. Gregory is an associate professor of orthopaedics, neurosurgery & pediatrics at Vanderbilt University in Nashville, Tenn., and serves as codirector of the Vanderbilt Sports Concussion Center. He had no financial conflicts to disclose.
“I think it is quite timely with the obesity epidemic and lack of PE in schools to highlight how important physical activity is for children, and organized sports is one of the ways to accomplish that,” Andrew Gregory, MD, said in an interview.
“I think the summary of both benefits and risks is well informed and complete,” he said.
However, “I think most pediatricians and parents are aware of the physical benefits of exercise, but many may be unaware of the psychological and social benefits,” Dr. Gregory noted. “It is also important that parents and coaches understand that bullying and hazing have no place in organized sports and should not be tolerated.”
“I think the most important thing for clinicians to pass on is that the benefits of organized sports far outweigh the risks,” he said. The challenge is, “How do we better incorporate organized sports into schools and community organizations so that more children have access?”
Dr. Gregory is an associate professor of orthopaedics, neurosurgery & pediatrics at Vanderbilt University in Nashville, Tenn., and serves as codirector of the Vanderbilt Sports Concussion Center. He had no financial conflicts to disclose.
according to a clinical report from the American Academy of Pediatrics’ Council on Sports Medicine and Fitness.
In the report, “Organized Sports for Children, Preadolescents, and Adolescents,” published online in Pediatrics, the authors addressed the risks and benefits of organized sports for children and teens and offered guidance for how clinicians, schools, and communities can involve more children in sports programs.
The authors emphasized the role of free play and the development of skills for children younger than 6 years. However, they wrote that you and parents should encourage organized sports – with emphasis on physical activity enjoyment – for children older than 6 years at a range of skill levels.
“Aspects of readiness to consider are motor skill acquisition, ability to combine those skills, and attention span,” according to the authors, who noted that most children younger than 6 years may not yet have the skills and attention for organized sports.
You also can remind parents to step back from pushing children into particular sports. Allowing children to choose which activities to try helps keep the focus on fun, even if the child’s idea of fun may differ from parental ideas. “Forcing children to participate in organized sports (or any physical activity) is likely to decrease fun in the activity and discourage future participation,” according to the authors.
They recognize barriers to organized sports for children from low socioeconomic backgrounds and advise communities to try to reduce them; other recommendations include having more options for organized sports at a range of skill levels to encourage participation and long-term involvement, and promoting physical activity.
“If we offer children a variety of sports for all skill levels, they are more likely to try new activities and stick with the ones they enjoy,” Kelsey Logan, MD, a coauthor of the report, said in a statement. “The interest should start with the child, not the parent.”
“Families can help by encouraging children to ‘sample’ sports, so they can figure out what they find enjoyable,” he said. “Ideally, there is an activity for everyone, with the focus on having fun.”
“Given the epidemic of obesity and all of its accompanying medical conditions, it is important to find ways to keep kids physically active. Organized sports participation is one tactic to accomplish this,” the authors said.
They acknowledge the potential risks involved in organized sports such as sports injuries, bullying, and burnout, but also advise empowering parents to support a positive coaching environment with playing time for all participants so they can enjoy the physical and mental benefits of being on a team.
“Young athletes typically learn skills and values that they can use in everyday life,” Steven Cuff, MD, coauthor of the report, said in a statement. “The camaraderie and teamwork needed on a playing field offers lasting lessons on personal responsibility, sportsmanship, goal-setting, and emotional control.”
Children with developmental and neurologic disabilities also can benefit from organized sports participation in programs such as Special Olympics, the authors said.
The report authors had no financial conflicts to disclose.
SOURCE: Logan K et al. Pediatrics. 2019 May 20. doi: 10.1542/peds.2019-0997.
according to a clinical report from the American Academy of Pediatrics’ Council on Sports Medicine and Fitness.
In the report, “Organized Sports for Children, Preadolescents, and Adolescents,” published online in Pediatrics, the authors addressed the risks and benefits of organized sports for children and teens and offered guidance for how clinicians, schools, and communities can involve more children in sports programs.
The authors emphasized the role of free play and the development of skills for children younger than 6 years. However, they wrote that you and parents should encourage organized sports – with emphasis on physical activity enjoyment – for children older than 6 years at a range of skill levels.
“Aspects of readiness to consider are motor skill acquisition, ability to combine those skills, and attention span,” according to the authors, who noted that most children younger than 6 years may not yet have the skills and attention for organized sports.
You also can remind parents to step back from pushing children into particular sports. Allowing children to choose which activities to try helps keep the focus on fun, even if the child’s idea of fun may differ from parental ideas. “Forcing children to participate in organized sports (or any physical activity) is likely to decrease fun in the activity and discourage future participation,” according to the authors.
They recognize barriers to organized sports for children from low socioeconomic backgrounds and advise communities to try to reduce them; other recommendations include having more options for organized sports at a range of skill levels to encourage participation and long-term involvement, and promoting physical activity.
“If we offer children a variety of sports for all skill levels, they are more likely to try new activities and stick with the ones they enjoy,” Kelsey Logan, MD, a coauthor of the report, said in a statement. “The interest should start with the child, not the parent.”
“Families can help by encouraging children to ‘sample’ sports, so they can figure out what they find enjoyable,” he said. “Ideally, there is an activity for everyone, with the focus on having fun.”
“Given the epidemic of obesity and all of its accompanying medical conditions, it is important to find ways to keep kids physically active. Organized sports participation is one tactic to accomplish this,” the authors said.
They acknowledge the potential risks involved in organized sports such as sports injuries, bullying, and burnout, but also advise empowering parents to support a positive coaching environment with playing time for all participants so they can enjoy the physical and mental benefits of being on a team.
“Young athletes typically learn skills and values that they can use in everyday life,” Steven Cuff, MD, coauthor of the report, said in a statement. “The camaraderie and teamwork needed on a playing field offers lasting lessons on personal responsibility, sportsmanship, goal-setting, and emotional control.”
Children with developmental and neurologic disabilities also can benefit from organized sports participation in programs such as Special Olympics, the authors said.
The report authors had no financial conflicts to disclose.
SOURCE: Logan K et al. Pediatrics. 2019 May 20. doi: 10.1542/peds.2019-0997.
FROM PEDIATRICS
Hormone use linked to hair loss in transgender adults
Gender-affirming hormone use was significantly associated with reports of androgenetic alopecia in transgender men, based on data from a survey of 991 individuals.
Given the importance of hair in body image and gender identity, hair concerns are important to the quality of life of gender-minority individuals, wrote Dustin Marks, of Massachusetts General Hospital, Boston, and colleagues.
To explore the impact of hormone use on hair loss in gender-minority patients, the researchers conducted a web-based survey of transgender individuals aged 18 years and older, who self-identified as gender minority. Participants were invited based on profiles on Facebook, YouTube, and Instagram. The findings were published in a research letter in the British Journal of Dermatology.
The 991 survey respondents included 59% transmen, 31% transwomen, and 9% gender nonbinary or gender queer. The average age of the participants was 33 years; 79% were white, 89% had medical insurance, and 91% reported using gender-affirming hormones.
Overall, 65% of transwomen, 43% of transmen, and 35% of nonbinary individuals reported scalp hair loss or thinning. Scalp hair loss was significantly more common among transmen on masculinizing hormones compared to transmen not on hormones (45% vs. 17%). Scalp hair loss was not significantly different between transwomen on feminizing hormones and those not on hormones.
The transwomen who reported scalp hair loss and were on hormones reported significantly less severe Sinclair grades, compared with transwomen with scalp hair loss and were not on hormones. By contrast, transmen and nonbinary individuals on testosterone reported significantly more hair loss (using Hamilton-Norwood and Sinclair scores) between a baseline before hormone use and their present state of hormone use.
The findings support the impact of testosterone use on androgenic alopecia (AGA) in gender-minority patients similar to the established role of testosterone in male pattern hair loss overall, the researchers wrote.
“Some transmen, moreover, may view AGA as a wanted masculine trait, while others seek dermatologic evaluation and treatment for their hair loss,” they noted. By contrast, some transwomen may find AGA especially distressing. In this study, AGA scores were stable for transwomen, which suggests that feminizing hormones may be enough to stabilize hair loss in these patients.
The study was limited by several factors including use of a convenience sample study population without cisgender controls, lack of data on the duration of hormone use, and specific focus on AGE, the researchers noted.
“Mindful of these limitations, clinicians should appreciate the impact of gender-affirming hormones on androgenetic alopecia severity and continue to address the hair concerns of each patient individually,” they wrote.
The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
SOURCE: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
Gender-affirming hormone use was significantly associated with reports of androgenetic alopecia in transgender men, based on data from a survey of 991 individuals.
Given the importance of hair in body image and gender identity, hair concerns are important to the quality of life of gender-minority individuals, wrote Dustin Marks, of Massachusetts General Hospital, Boston, and colleagues.
To explore the impact of hormone use on hair loss in gender-minority patients, the researchers conducted a web-based survey of transgender individuals aged 18 years and older, who self-identified as gender minority. Participants were invited based on profiles on Facebook, YouTube, and Instagram. The findings were published in a research letter in the British Journal of Dermatology.
The 991 survey respondents included 59% transmen, 31% transwomen, and 9% gender nonbinary or gender queer. The average age of the participants was 33 years; 79% were white, 89% had medical insurance, and 91% reported using gender-affirming hormones.
Overall, 65% of transwomen, 43% of transmen, and 35% of nonbinary individuals reported scalp hair loss or thinning. Scalp hair loss was significantly more common among transmen on masculinizing hormones compared to transmen not on hormones (45% vs. 17%). Scalp hair loss was not significantly different between transwomen on feminizing hormones and those not on hormones.
The transwomen who reported scalp hair loss and were on hormones reported significantly less severe Sinclair grades, compared with transwomen with scalp hair loss and were not on hormones. By contrast, transmen and nonbinary individuals on testosterone reported significantly more hair loss (using Hamilton-Norwood and Sinclair scores) between a baseline before hormone use and their present state of hormone use.
The findings support the impact of testosterone use on androgenic alopecia (AGA) in gender-minority patients similar to the established role of testosterone in male pattern hair loss overall, the researchers wrote.
“Some transmen, moreover, may view AGA as a wanted masculine trait, while others seek dermatologic evaluation and treatment for their hair loss,” they noted. By contrast, some transwomen may find AGA especially distressing. In this study, AGA scores were stable for transwomen, which suggests that feminizing hormones may be enough to stabilize hair loss in these patients.
The study was limited by several factors including use of a convenience sample study population without cisgender controls, lack of data on the duration of hormone use, and specific focus on AGE, the researchers noted.
“Mindful of these limitations, clinicians should appreciate the impact of gender-affirming hormones on androgenetic alopecia severity and continue to address the hair concerns of each patient individually,” they wrote.
The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
SOURCE: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
Gender-affirming hormone use was significantly associated with reports of androgenetic alopecia in transgender men, based on data from a survey of 991 individuals.
Given the importance of hair in body image and gender identity, hair concerns are important to the quality of life of gender-minority individuals, wrote Dustin Marks, of Massachusetts General Hospital, Boston, and colleagues.
To explore the impact of hormone use on hair loss in gender-minority patients, the researchers conducted a web-based survey of transgender individuals aged 18 years and older, who self-identified as gender minority. Participants were invited based on profiles on Facebook, YouTube, and Instagram. The findings were published in a research letter in the British Journal of Dermatology.
The 991 survey respondents included 59% transmen, 31% transwomen, and 9% gender nonbinary or gender queer. The average age of the participants was 33 years; 79% were white, 89% had medical insurance, and 91% reported using gender-affirming hormones.
Overall, 65% of transwomen, 43% of transmen, and 35% of nonbinary individuals reported scalp hair loss or thinning. Scalp hair loss was significantly more common among transmen on masculinizing hormones compared to transmen not on hormones (45% vs. 17%). Scalp hair loss was not significantly different between transwomen on feminizing hormones and those not on hormones.
The transwomen who reported scalp hair loss and were on hormones reported significantly less severe Sinclair grades, compared with transwomen with scalp hair loss and were not on hormones. By contrast, transmen and nonbinary individuals on testosterone reported significantly more hair loss (using Hamilton-Norwood and Sinclair scores) between a baseline before hormone use and their present state of hormone use.
The findings support the impact of testosterone use on androgenic alopecia (AGA) in gender-minority patients similar to the established role of testosterone in male pattern hair loss overall, the researchers wrote.
“Some transmen, moreover, may view AGA as a wanted masculine trait, while others seek dermatologic evaluation and treatment for their hair loss,” they noted. By contrast, some transwomen may find AGA especially distressing. In this study, AGA scores were stable for transwomen, which suggests that feminizing hormones may be enough to stabilize hair loss in these patients.
The study was limited by several factors including use of a convenience sample study population without cisgender controls, lack of data on the duration of hormone use, and specific focus on AGE, the researchers noted.
“Mindful of these limitations, clinicians should appreciate the impact of gender-affirming hormones on androgenetic alopecia severity and continue to address the hair concerns of each patient individually,” they wrote.
The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
SOURCE: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Key clinical point: Use of hormone therapy had a significant impact on scalp and hair loss in trans men who used masculinizing hormones.
Major finding: Scalp hair loss or hair thinning was reported by 65% of trans women, 43% of trans men, and 35% of nonbinary individuals.
Study details: The data come from a cross-sectional study including 991 adults self-identifying as gender minorities.
Disclosures: The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
Source: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
No raised risk of cardiovascular events for COPD patients on aclidinium
, compared with placebo, in a randomized trial of more than 3,000 patients.
Aclidinium, a long-acting muscarinic antagonist (LAMA), has been shown to reduce COPD exacerbation in the short term, but long-term effectiveness has not been examined, wrote Robert A. Wise, MD, of Johns Hopkins University, Baltimore, and colleagues.
ASCENT-COPD is a multicenter, double-blind, randomized, placebo-controlled, parallel-group noninferiority study conducted at 522 sites in the United States and Canada. A paper on recent data from ASCENT-COPD, published in JAMA, supports early findings reported last year at the American Thoracic Society meeting.
The researchers randomized adults with COPD to a 400-mg dose of aclidinium bromide twice daily, or placebo. The average age of the patients was 67 years; 59% were men. The median exposure time to aclidinium or placebo was 365 days during the first year of treatment, and the median exposure overall was 495 days for aclidinium patients and 478 days for placebo patients.
Of the 2,537 patients who completed the study, 69 (3.9%) in the aclidinium group and 76 (4.2%) in the placebo group experienced a major adverse cardiovascular event (MACE, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).
In addition, annual rates of moderate to severe COPD exacerbations were significantly lower in the aclidinium patients compared with placebo patients (0.44 vs. 0.57, P less than .001).
In a secondary analysis with a definition of MACE expanded to include heart failure, arrhythmias, or cerebrovascular disease, results remained similar between the groups; events occurred in 168 aclidinium patients (9.4%) and 160 placebo patients (8.9%). The rate of COPD exacerbations requiring hospitalization was significantly lower in aclidinium patients, compared with placebo patients (0.07 vs. 0.10, P = .006).
Overall, the most common treatment-emergent adverse events were similar in the aclidinium and placebo groups, respectively; pneumonia (6.1% vs. 5.8%), urinary tract infections (5.2% vs. 5.0%), and upper respiratory tract infections (4.8% vs. 5.6%). The most common serious adverse events (in at least 1% of patients) were pneumonia, atrial fibrillation, heart failure, and coronary artery disease. Dry mouth and urinary retention were rare, and occurred in less than 1% of patients in each group.
“No patient subgroup demonstrated a difference in efficacy except when analyzed by baseline COPD severity, in which the treatment benefit was observed only in patients with FEV1 [forced expiratory volume in 1 second] of 50% predicted or less,” the researchers noted. “This may be explained by the lower exacerbation rate seen in the placebo group in patients with moderate airway obstruction vs. severe or very severe obstruction,” they said.
“Outcomes of this trial add data to the long-standing controversy over the safety of LAMAs in COPD” and support the need for additional research, they said.
The study findings were limited by several factors including insufficient power to detect cause-specific mortality and the use of a LAMA with low risk of systemic effects, the researchers noted.
SOURCE: Wise R et al. JAMA. 2019. 321:1693-1701.
, compared with placebo, in a randomized trial of more than 3,000 patients.
Aclidinium, a long-acting muscarinic antagonist (LAMA), has been shown to reduce COPD exacerbation in the short term, but long-term effectiveness has not been examined, wrote Robert A. Wise, MD, of Johns Hopkins University, Baltimore, and colleagues.
ASCENT-COPD is a multicenter, double-blind, randomized, placebo-controlled, parallel-group noninferiority study conducted at 522 sites in the United States and Canada. A paper on recent data from ASCENT-COPD, published in JAMA, supports early findings reported last year at the American Thoracic Society meeting.
The researchers randomized adults with COPD to a 400-mg dose of aclidinium bromide twice daily, or placebo. The average age of the patients was 67 years; 59% were men. The median exposure time to aclidinium or placebo was 365 days during the first year of treatment, and the median exposure overall was 495 days for aclidinium patients and 478 days for placebo patients.
Of the 2,537 patients who completed the study, 69 (3.9%) in the aclidinium group and 76 (4.2%) in the placebo group experienced a major adverse cardiovascular event (MACE, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).
In addition, annual rates of moderate to severe COPD exacerbations were significantly lower in the aclidinium patients compared with placebo patients (0.44 vs. 0.57, P less than .001).
In a secondary analysis with a definition of MACE expanded to include heart failure, arrhythmias, or cerebrovascular disease, results remained similar between the groups; events occurred in 168 aclidinium patients (9.4%) and 160 placebo patients (8.9%). The rate of COPD exacerbations requiring hospitalization was significantly lower in aclidinium patients, compared with placebo patients (0.07 vs. 0.10, P = .006).
Overall, the most common treatment-emergent adverse events were similar in the aclidinium and placebo groups, respectively; pneumonia (6.1% vs. 5.8%), urinary tract infections (5.2% vs. 5.0%), and upper respiratory tract infections (4.8% vs. 5.6%). The most common serious adverse events (in at least 1% of patients) were pneumonia, atrial fibrillation, heart failure, and coronary artery disease. Dry mouth and urinary retention were rare, and occurred in less than 1% of patients in each group.
“No patient subgroup demonstrated a difference in efficacy except when analyzed by baseline COPD severity, in which the treatment benefit was observed only in patients with FEV1 [forced expiratory volume in 1 second] of 50% predicted or less,” the researchers noted. “This may be explained by the lower exacerbation rate seen in the placebo group in patients with moderate airway obstruction vs. severe or very severe obstruction,” they said.
“Outcomes of this trial add data to the long-standing controversy over the safety of LAMAs in COPD” and support the need for additional research, they said.
The study findings were limited by several factors including insufficient power to detect cause-specific mortality and the use of a LAMA with low risk of systemic effects, the researchers noted.
SOURCE: Wise R et al. JAMA. 2019. 321:1693-1701.
, compared with placebo, in a randomized trial of more than 3,000 patients.
Aclidinium, a long-acting muscarinic antagonist (LAMA), has been shown to reduce COPD exacerbation in the short term, but long-term effectiveness has not been examined, wrote Robert A. Wise, MD, of Johns Hopkins University, Baltimore, and colleagues.
ASCENT-COPD is a multicenter, double-blind, randomized, placebo-controlled, parallel-group noninferiority study conducted at 522 sites in the United States and Canada. A paper on recent data from ASCENT-COPD, published in JAMA, supports early findings reported last year at the American Thoracic Society meeting.
The researchers randomized adults with COPD to a 400-mg dose of aclidinium bromide twice daily, or placebo. The average age of the patients was 67 years; 59% were men. The median exposure time to aclidinium or placebo was 365 days during the first year of treatment, and the median exposure overall was 495 days for aclidinium patients and 478 days for placebo patients.
Of the 2,537 patients who completed the study, 69 (3.9%) in the aclidinium group and 76 (4.2%) in the placebo group experienced a major adverse cardiovascular event (MACE, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).
In addition, annual rates of moderate to severe COPD exacerbations were significantly lower in the aclidinium patients compared with placebo patients (0.44 vs. 0.57, P less than .001).
In a secondary analysis with a definition of MACE expanded to include heart failure, arrhythmias, or cerebrovascular disease, results remained similar between the groups; events occurred in 168 aclidinium patients (9.4%) and 160 placebo patients (8.9%). The rate of COPD exacerbations requiring hospitalization was significantly lower in aclidinium patients, compared with placebo patients (0.07 vs. 0.10, P = .006).
Overall, the most common treatment-emergent adverse events were similar in the aclidinium and placebo groups, respectively; pneumonia (6.1% vs. 5.8%), urinary tract infections (5.2% vs. 5.0%), and upper respiratory tract infections (4.8% vs. 5.6%). The most common serious adverse events (in at least 1% of patients) were pneumonia, atrial fibrillation, heart failure, and coronary artery disease. Dry mouth and urinary retention were rare, and occurred in less than 1% of patients in each group.
“No patient subgroup demonstrated a difference in efficacy except when analyzed by baseline COPD severity, in which the treatment benefit was observed only in patients with FEV1 [forced expiratory volume in 1 second] of 50% predicted or less,” the researchers noted. “This may be explained by the lower exacerbation rate seen in the placebo group in patients with moderate airway obstruction vs. severe or very severe obstruction,” they said.
“Outcomes of this trial add data to the long-standing controversy over the safety of LAMAs in COPD” and support the need for additional research, they said.
The study findings were limited by several factors including insufficient power to detect cause-specific mortality and the use of a LAMA with low risk of systemic effects, the researchers noted.
SOURCE: Wise R et al. JAMA. 2019. 321:1693-1701.
FROM JAMA
Biomarkers support impact of concussions on cognitive function
Former athletes with a history of concussion averaged higher levels of total tau in their cerebrospinal fluid than did healthy controls, and those with the highest levels showed signs of reduced cognitive function in a case-control study.
Chronic traumatic encephalopathy (CTE) remains a postmortem diagnosis, but “the potential for treating postconcussion degeneration such as CTE depends on being able to detect the in vivo pathology at an early stage to intervene before the disease progresses to an irreversible stage,” wrote Foad Taghdiri, MD, of the University of Toronto and colleagues.
In a study published in Neurology, the researchers measured concentrations of phosphorylated tau181, total tau (t-tau), and beta-amyloid in the cerebrospinal fluid (CSF) of three groups: 22 former professional athletes who had suffered multiple concussions, 5 healthy controls, and 12 individuals diagnosed with Alzheimer’s disease (AD). The average ages of the groups were 56 years, 57 years, and 60 years, respectively. All the athletes were male, and their sports included snowboarding, hockey, and football.
The average t-tau level in the CSF of the athletes was significantly higher than that of controls (349.3 pg/mL vs. 188.8 pg/mL) and significantly lower than that of AD patients (857.0 pg/mL).
Normal CSF t-tau was defined as 300 pg/mL, and 12 former athletes (45%) had high t-tau levels, with an average of 499.3 pg/mL. In this group of high t-tau former athletes, the average score on the Trail Making Test (TMT) Part B was significantly lower than the average score among the 10 former athletes with normal CSF t-tau levels (t scores 45.6 vs. 62.3; P = .017).
In addition, results from MRI scans showed that fractional anisotropy values across all the tracts were significantly lower for those with high CSF t-tau levels, compared with those who had normal CSF t-tau levels (P = .036).
The findings were limited by several factors, including the small sample size, lack of female athletes, and limited ability to compare white matter integrity between high and normal CSF t-tau groups, the researchers noted.
However, the results suggest that “multiple concussive or subconcussive events may trigger neurodegeneration to a greater degree than expected on the basis of age alone,” they said. Although the study did not allow for diagnosing the participants with CTE, “we are engaged in longitudinal studies to track neurologic and neuropsychological function, CSF biomarkers, and structural brain changes over time to further assess the delayed effects of multiple concussions on the brain,” the researchers wrote.
The study was funded by the Toronto General and Western Hospital Foundation, PSI Foundation, and the Canadian Institute of Health Research. The researchers had no financial conflicts to disclose.
SOURCE: Taghdiri F et al. Neurology. 2019 May 8. doi: 10.1212/WNL.0000000000007608
Former athletes with a history of concussion averaged higher levels of total tau in their cerebrospinal fluid than did healthy controls, and those with the highest levels showed signs of reduced cognitive function in a case-control study.
Chronic traumatic encephalopathy (CTE) remains a postmortem diagnosis, but “the potential for treating postconcussion degeneration such as CTE depends on being able to detect the in vivo pathology at an early stage to intervene before the disease progresses to an irreversible stage,” wrote Foad Taghdiri, MD, of the University of Toronto and colleagues.
In a study published in Neurology, the researchers measured concentrations of phosphorylated tau181, total tau (t-tau), and beta-amyloid in the cerebrospinal fluid (CSF) of three groups: 22 former professional athletes who had suffered multiple concussions, 5 healthy controls, and 12 individuals diagnosed with Alzheimer’s disease (AD). The average ages of the groups were 56 years, 57 years, and 60 years, respectively. All the athletes were male, and their sports included snowboarding, hockey, and football.
The average t-tau level in the CSF of the athletes was significantly higher than that of controls (349.3 pg/mL vs. 188.8 pg/mL) and significantly lower than that of AD patients (857.0 pg/mL).
Normal CSF t-tau was defined as 300 pg/mL, and 12 former athletes (45%) had high t-tau levels, with an average of 499.3 pg/mL. In this group of high t-tau former athletes, the average score on the Trail Making Test (TMT) Part B was significantly lower than the average score among the 10 former athletes with normal CSF t-tau levels (t scores 45.6 vs. 62.3; P = .017).
In addition, results from MRI scans showed that fractional anisotropy values across all the tracts were significantly lower for those with high CSF t-tau levels, compared with those who had normal CSF t-tau levels (P = .036).
The findings were limited by several factors, including the small sample size, lack of female athletes, and limited ability to compare white matter integrity between high and normal CSF t-tau groups, the researchers noted.
However, the results suggest that “multiple concussive or subconcussive events may trigger neurodegeneration to a greater degree than expected on the basis of age alone,” they said. Although the study did not allow for diagnosing the participants with CTE, “we are engaged in longitudinal studies to track neurologic and neuropsychological function, CSF biomarkers, and structural brain changes over time to further assess the delayed effects of multiple concussions on the brain,” the researchers wrote.
The study was funded by the Toronto General and Western Hospital Foundation, PSI Foundation, and the Canadian Institute of Health Research. The researchers had no financial conflicts to disclose.
SOURCE: Taghdiri F et al. Neurology. 2019 May 8. doi: 10.1212/WNL.0000000000007608
Former athletes with a history of concussion averaged higher levels of total tau in their cerebrospinal fluid than did healthy controls, and those with the highest levels showed signs of reduced cognitive function in a case-control study.
Chronic traumatic encephalopathy (CTE) remains a postmortem diagnosis, but “the potential for treating postconcussion degeneration such as CTE depends on being able to detect the in vivo pathology at an early stage to intervene before the disease progresses to an irreversible stage,” wrote Foad Taghdiri, MD, of the University of Toronto and colleagues.
In a study published in Neurology, the researchers measured concentrations of phosphorylated tau181, total tau (t-tau), and beta-amyloid in the cerebrospinal fluid (CSF) of three groups: 22 former professional athletes who had suffered multiple concussions, 5 healthy controls, and 12 individuals diagnosed with Alzheimer’s disease (AD). The average ages of the groups were 56 years, 57 years, and 60 years, respectively. All the athletes were male, and their sports included snowboarding, hockey, and football.
The average t-tau level in the CSF of the athletes was significantly higher than that of controls (349.3 pg/mL vs. 188.8 pg/mL) and significantly lower than that of AD patients (857.0 pg/mL).
Normal CSF t-tau was defined as 300 pg/mL, and 12 former athletes (45%) had high t-tau levels, with an average of 499.3 pg/mL. In this group of high t-tau former athletes, the average score on the Trail Making Test (TMT) Part B was significantly lower than the average score among the 10 former athletes with normal CSF t-tau levels (t scores 45.6 vs. 62.3; P = .017).
In addition, results from MRI scans showed that fractional anisotropy values across all the tracts were significantly lower for those with high CSF t-tau levels, compared with those who had normal CSF t-tau levels (P = .036).
The findings were limited by several factors, including the small sample size, lack of female athletes, and limited ability to compare white matter integrity between high and normal CSF t-tau groups, the researchers noted.
However, the results suggest that “multiple concussive or subconcussive events may trigger neurodegeneration to a greater degree than expected on the basis of age alone,” they said. Although the study did not allow for diagnosing the participants with CTE, “we are engaged in longitudinal studies to track neurologic and neuropsychological function, CSF biomarkers, and structural brain changes over time to further assess the delayed effects of multiple concussions on the brain,” the researchers wrote.
The study was funded by the Toronto General and Western Hospital Foundation, PSI Foundation, and the Canadian Institute of Health Research. The researchers had no financial conflicts to disclose.
SOURCE: Taghdiri F et al. Neurology. 2019 May 8. doi: 10.1212/WNL.0000000000007608
FROM NEUROLOGY
PCV13 vaccine reduces frequency of otitis media visits
The mean number of office visits for otitis media in children younger than 5 years dropped significantly after the introduction of the 13-valent pneumococcal conjugate vaccine, according to findings published in the International Journal of Pediatric Otorhinolaryngology.
Previous studies have shown that more than half of children with otitis media (OM) have serotypes included in the PCV7 vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F), wrote Xiaofeng Zhou, MD, of Pfizer, New York, and colleagues.
To assess the impact of PCV13, with the additional serotypes 1, 3, 5, 6A, 7F, and 19A, the researchers analyzed data from the U.S. National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey for three time periods: pre-PCV7 (1997-1999), after the introduction of PCV7 (2001-2009), and after the introduction of PCV13 (2011-2013).
Between the pre-PCV7 and PCV13 time periods, the researchers found significant reductions in the mean rates of OM visits of 48% and 41% among children younger than 2 years and younger than 5 years, respectively; reductions were 24% and 22%, respectively, when comparing PCV13 and PCV7. Ambulatory care visits for skin rash and trauma were not significantly different among the study periods.
Comparing the PCV7 and PCV13 time periods, the mean number of OM visits per 100 children declined from 84 to 64 per 100 children younger than 2 years, 41 to 34 per 100 children between ages 2 and 5 years, and from 59 to 46 per 100 children younger than 5 years.
The study findings were limited by several factors including the use of an ecologic study design, which was chosen to help reduce selection bias, but that did not show evidence of the field effectiveness of the PCV13 vaccine. Another limitation was the potential misclassification of patients with OM given clinician variability in diagnostic criteria, the researchers noted.
“Our results in this study, while not providing direct evidence of causality, nonetheless suggest a significant and positive impact of the PCV13 vaccination program on otitis media for children less than 5 years of age in the U.S., with further reductions in OM visits observed in PCV13 period following a decade of PCV7 use,” Dr. Zhou and associates said.
The investigators are employed by Pfizer, which funded the study.
SOURCE: Zhou X et al. Int J Pediatr Otorhinolaryngol. 2019 Apr. 119:96-102.
The mean number of office visits for otitis media in children younger than 5 years dropped significantly after the introduction of the 13-valent pneumococcal conjugate vaccine, according to findings published in the International Journal of Pediatric Otorhinolaryngology.
Previous studies have shown that more than half of children with otitis media (OM) have serotypes included in the PCV7 vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F), wrote Xiaofeng Zhou, MD, of Pfizer, New York, and colleagues.
To assess the impact of PCV13, with the additional serotypes 1, 3, 5, 6A, 7F, and 19A, the researchers analyzed data from the U.S. National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey for three time periods: pre-PCV7 (1997-1999), after the introduction of PCV7 (2001-2009), and after the introduction of PCV13 (2011-2013).
Between the pre-PCV7 and PCV13 time periods, the researchers found significant reductions in the mean rates of OM visits of 48% and 41% among children younger than 2 years and younger than 5 years, respectively; reductions were 24% and 22%, respectively, when comparing PCV13 and PCV7. Ambulatory care visits for skin rash and trauma were not significantly different among the study periods.
Comparing the PCV7 and PCV13 time periods, the mean number of OM visits per 100 children declined from 84 to 64 per 100 children younger than 2 years, 41 to 34 per 100 children between ages 2 and 5 years, and from 59 to 46 per 100 children younger than 5 years.
The study findings were limited by several factors including the use of an ecologic study design, which was chosen to help reduce selection bias, but that did not show evidence of the field effectiveness of the PCV13 vaccine. Another limitation was the potential misclassification of patients with OM given clinician variability in diagnostic criteria, the researchers noted.
“Our results in this study, while not providing direct evidence of causality, nonetheless suggest a significant and positive impact of the PCV13 vaccination program on otitis media for children less than 5 years of age in the U.S., with further reductions in OM visits observed in PCV13 period following a decade of PCV7 use,” Dr. Zhou and associates said.
The investigators are employed by Pfizer, which funded the study.
SOURCE: Zhou X et al. Int J Pediatr Otorhinolaryngol. 2019 Apr. 119:96-102.
The mean number of office visits for otitis media in children younger than 5 years dropped significantly after the introduction of the 13-valent pneumococcal conjugate vaccine, according to findings published in the International Journal of Pediatric Otorhinolaryngology.
Previous studies have shown that more than half of children with otitis media (OM) have serotypes included in the PCV7 vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F), wrote Xiaofeng Zhou, MD, of Pfizer, New York, and colleagues.
To assess the impact of PCV13, with the additional serotypes 1, 3, 5, 6A, 7F, and 19A, the researchers analyzed data from the U.S. National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey for three time periods: pre-PCV7 (1997-1999), after the introduction of PCV7 (2001-2009), and after the introduction of PCV13 (2011-2013).
Between the pre-PCV7 and PCV13 time periods, the researchers found significant reductions in the mean rates of OM visits of 48% and 41% among children younger than 2 years and younger than 5 years, respectively; reductions were 24% and 22%, respectively, when comparing PCV13 and PCV7. Ambulatory care visits for skin rash and trauma were not significantly different among the study periods.
Comparing the PCV7 and PCV13 time periods, the mean number of OM visits per 100 children declined from 84 to 64 per 100 children younger than 2 years, 41 to 34 per 100 children between ages 2 and 5 years, and from 59 to 46 per 100 children younger than 5 years.
The study findings were limited by several factors including the use of an ecologic study design, which was chosen to help reduce selection bias, but that did not show evidence of the field effectiveness of the PCV13 vaccine. Another limitation was the potential misclassification of patients with OM given clinician variability in diagnostic criteria, the researchers noted.
“Our results in this study, while not providing direct evidence of causality, nonetheless suggest a significant and positive impact of the PCV13 vaccination program on otitis media for children less than 5 years of age in the U.S., with further reductions in OM visits observed in PCV13 period following a decade of PCV7 use,” Dr. Zhou and associates said.
The investigators are employed by Pfizer, which funded the study.
SOURCE: Zhou X et al. Int J Pediatr Otorhinolaryngol. 2019 Apr. 119:96-102.
FROM THE INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY
Aspirin did not improve sensitivity of fecal immunochemical test
The study was inspired by an observational study in which the sensitivity of the fecal immunochemical test (FIT) was enhanced in adults taking aspirin for cardiovascular disease prevention.
It was surmised that “aspirin predisposes to subclinical bleeding and, hence, increased detection of advanced adenomas by FIT. This suggests that administration of aspirin prior to fecal sampling might be a practical intervention to increase FIT sensitivity,” wrote Hermann Brenner, MD, of the German Cancer Research Center, Heidelberg, and colleagues.
In a study published in JAMA, the researchers analyzed 2,134 adults aged 40-80 years who were scheduled for colonoscopy. The study participants, who had no recent use of aspirin or other drugs with antithrombotic effects, were randomized to a 300-mg aspirin tablet or a placebo tablet 2 days before stool samples were obtained. The average age of the participants was 60 years, and 78% of the colonoscopies were for primary screening.
Overall, 224 of the study participants had advanced neoplasms, including 216 individuals with advanced adenoma and 8 with colorectal cancer.
Sensitivity was not significantly different between the aspirin and placebo groups at either of two predefined cutoffs of 10.2-mcg Hb/g stool (40.2% and 30.4%, respectively) and 17-mcg Hb/g stool (28.6% and 22.5%, respectively).
Two serious adverse events occurred in the aspirin group but were not considered related to aspirin. No serious adverse events were reported in the placebo group.
Although the results do not support the findings from previous observational studies, they suggest the need for more research of the potential impact of aspirin on FIT sensitivity, the researchers said.
“This trial was designed to detect a 24% absolute increase in sensitivity and was not adequately powered to detect small differences that may nevertheless be clinically meaningful given the low morbidity observed, the low cost of a single dose of aspirin, and the ease of implementation of this intervention across health systems,” they explained.
Additional limitations of the study included lack of adjustment for multiple testing in secondary analyses, inability to analyze subtypes of advanced neoplasms, and the inclusion of only one round of screening. FIT programs usually include multiple rounds, the researchers said. Therefore, “potential effects on detection of advanced neoplasms and reduction of CRC incidence and mortality in the long run are yet to be determined.”
SOURCE: Brenner H et al. JAMA. 2019;321(17):1686-1692.
The study was inspired by an observational study in which the sensitivity of the fecal immunochemical test (FIT) was enhanced in adults taking aspirin for cardiovascular disease prevention.
It was surmised that “aspirin predisposes to subclinical bleeding and, hence, increased detection of advanced adenomas by FIT. This suggests that administration of aspirin prior to fecal sampling might be a practical intervention to increase FIT sensitivity,” wrote Hermann Brenner, MD, of the German Cancer Research Center, Heidelberg, and colleagues.
In a study published in JAMA, the researchers analyzed 2,134 adults aged 40-80 years who were scheduled for colonoscopy. The study participants, who had no recent use of aspirin or other drugs with antithrombotic effects, were randomized to a 300-mg aspirin tablet or a placebo tablet 2 days before stool samples were obtained. The average age of the participants was 60 years, and 78% of the colonoscopies were for primary screening.
Overall, 224 of the study participants had advanced neoplasms, including 216 individuals with advanced adenoma and 8 with colorectal cancer.
Sensitivity was not significantly different between the aspirin and placebo groups at either of two predefined cutoffs of 10.2-mcg Hb/g stool (40.2% and 30.4%, respectively) and 17-mcg Hb/g stool (28.6% and 22.5%, respectively).
Two serious adverse events occurred in the aspirin group but were not considered related to aspirin. No serious adverse events were reported in the placebo group.
Although the results do not support the findings from previous observational studies, they suggest the need for more research of the potential impact of aspirin on FIT sensitivity, the researchers said.
“This trial was designed to detect a 24% absolute increase in sensitivity and was not adequately powered to detect small differences that may nevertheless be clinically meaningful given the low morbidity observed, the low cost of a single dose of aspirin, and the ease of implementation of this intervention across health systems,” they explained.
Additional limitations of the study included lack of adjustment for multiple testing in secondary analyses, inability to analyze subtypes of advanced neoplasms, and the inclusion of only one round of screening. FIT programs usually include multiple rounds, the researchers said. Therefore, “potential effects on detection of advanced neoplasms and reduction of CRC incidence and mortality in the long run are yet to be determined.”
SOURCE: Brenner H et al. JAMA. 2019;321(17):1686-1692.
The study was inspired by an observational study in which the sensitivity of the fecal immunochemical test (FIT) was enhanced in adults taking aspirin for cardiovascular disease prevention.
It was surmised that “aspirin predisposes to subclinical bleeding and, hence, increased detection of advanced adenomas by FIT. This suggests that administration of aspirin prior to fecal sampling might be a practical intervention to increase FIT sensitivity,” wrote Hermann Brenner, MD, of the German Cancer Research Center, Heidelberg, and colleagues.
In a study published in JAMA, the researchers analyzed 2,134 adults aged 40-80 years who were scheduled for colonoscopy. The study participants, who had no recent use of aspirin or other drugs with antithrombotic effects, were randomized to a 300-mg aspirin tablet or a placebo tablet 2 days before stool samples were obtained. The average age of the participants was 60 years, and 78% of the colonoscopies were for primary screening.
Overall, 224 of the study participants had advanced neoplasms, including 216 individuals with advanced adenoma and 8 with colorectal cancer.
Sensitivity was not significantly different between the aspirin and placebo groups at either of two predefined cutoffs of 10.2-mcg Hb/g stool (40.2% and 30.4%, respectively) and 17-mcg Hb/g stool (28.6% and 22.5%, respectively).
Two serious adverse events occurred in the aspirin group but were not considered related to aspirin. No serious adverse events were reported in the placebo group.
Although the results do not support the findings from previous observational studies, they suggest the need for more research of the potential impact of aspirin on FIT sensitivity, the researchers said.
“This trial was designed to detect a 24% absolute increase in sensitivity and was not adequately powered to detect small differences that may nevertheless be clinically meaningful given the low morbidity observed, the low cost of a single dose of aspirin, and the ease of implementation of this intervention across health systems,” they explained.
Additional limitations of the study included lack of adjustment for multiple testing in secondary analyses, inability to analyze subtypes of advanced neoplasms, and the inclusion of only one round of screening. FIT programs usually include multiple rounds, the researchers said. Therefore, “potential effects on detection of advanced neoplasms and reduction of CRC incidence and mortality in the long run are yet to be determined.”
SOURCE: Brenner H et al. JAMA. 2019;321(17):1686-1692.
FROM JAMA
Key clinical point: A dose of aspirin did not improve fecal immunochemical test (FIT) sensitivity to detect colorectal neoplasms in adults with no recent use of aspirin or other drugs with antithrombotic effects.
Major finding: Sensitivity of the FIT test was 40% in the aspirin group and 30% in the placebo group, a nonsignificant difference.
Study details: The data come from a randomized trial of 2,134 adults who received aspirin or placebo 2 days before stool sampling for FIT. The study participants were scheduled for colonoscopy at 14 gastroenterology practices and 4 hospitals in Germany.
Disclosures: Lead author Dr. Brenner disclosed grants from the German Federal Ministry of Education and Research, which funded the study, as well as the German Cancer Aid, the European Commission, the U.S. National Institutes of Health, Applied Proteomics, Roche Diagnostics, Volition, and Goodgut during the study period.
Source: Brenner H et al. JAMA. 2019;321(17):1686-92.